Quality Management of Personalized Implants: Impact of New Regulations
By Axel Dubois and Julien Deckx
Personalized implants have become a key part of the offering for orthopaedic, dental, and cranio-maxillofacial surgery, with proven outcomes. However, because of the specific regulatory situation of such implants, the quality of such products varies widely depending on the manufacturer. Additionally, the regulatory situation has evolved drastically in recent times.
In this webinar, Axel Dubois, CEO at SLS France, elaborates on the efforts and challenges related to the proper validation of the full workflow to design and manufacture personalized implants.
In this recording, you will learn :
- What steps go into the process to create and validate qualitative personalized implants
- How recent regulatory changes affect this effort
- What to ask to manufacturers about the safety and quality of their personalized products
- What the advantages are of using certified software for designing personalized implants
Julien Deckx is market manager for orthopedic and cranio-maxillo-facial software solutions at Materialise. Julien first worked as a Junior Research Engineer at former Materialise subsidiary Mobelife, which developed, among other products, aMace, the 3D printed patient-specific hip implant. He then led the ADAM services team from 2011 to 2018, providing virtual patient analysis and 3D printing services to companies worldwide. Julien holds a MSc in Biomedical Engineering degree at the University of Leuven.
Axel Dubois has been Chief Executive Officer of SLS France since he founded the company in January 2014. SLS France was born out of the ambitions of Axel to create a company since he discovered 3D printing technologies at 19 years old. Continuing his studies with this project in mind, he started to learn and accumulate skills and knowledge on the technology by reading theses, publications, and doing internships in organizations working on this future technology revolution. After obtaining degrees in engineering and finance, he created the company.
Since the beginning, the success of SLS France has been the same: to deliver a required product for the customer-specific needs. SLS believes the customer is important, and in its market a small company could be the leader of tomorrow. The transformation rate is 95% when a customer tries additive metal with SLS France.
Today, SLS France is known by its capacity to create workflows for their customers from idea to serial product. 10% of the team works on quality and regulatory affairs, and various team members hold PhDs in materials and biologics. These skills are the basis for SLS France to participate in ambitious projects such as Followknee, a 28 million euro initiative for orthopaedic knee implants, or OCR3D, which is specializing in new orthodontics appliances made by numeric product and industrial processing.